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Sponsors and Collaborators: |
Immutep S.A. Umanis (CRO) |
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Information provided by: | Immutep S.A. |
ClinicalTrials.gov Identifier: | NCT00351949 |
Single-center, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting
Condition | Intervention | Phase |
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Stage IV Renal Cell Carcinoma |
Biological: IMP321 |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
Official Title: | IMP321 Phase 1 Study in Advanced or Metastatic Renal Cell Carcinoma Patients (P003) |
Estimated Enrollment: | 24 |
Study Start Date: | September 2005 |
Estimated Study Completion Date: | November 2008 |
Estimated Primary Completion Date: | October 2008 (Final data collection date for primary outcome measure) |
This is a single-center, single-arm, open label, non-randomized, fixed dose-escalation, phase 1 study, performed in ambulatory and day-hospital setting. After a screening period, patients will enter a drug administration period, followed by a 'post-study' period.
Four IMP321 dose levels, 50 µg, 250 µg, 1.250 mg, 6.250 mg and 30 mg will be evaluated in successive cohorts of patients. At any given dose level 3 patients will be administered one subcutaneous dose every 2 weeks for a total of 12 weeks (6 injections in total), separated by 13-day administration-free intervals.
The next (higher) dose level will be dosed to 3 new patients if the previous dose level has been well tolerated. Investigator will decide whether the safety is acceptable by performing an evaluation after the third administration (at week 8) and if the next patients can be included.
The successive cohorts of patients are summarized as follows:
Once the main period of study has been completed, namely two weeks after a cohort is completed, i.e. at week 14, all patients will undergo an ambulatory 'post-study' examination.
Patients of the Cohort B, C, E, F and G will participate in a pharmacokinetic (PK) study and all patients in a pharmacodynamic (PD) study involving additional blood samples.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Bernard Escudier, M.D | +33 (0)1 42 11 44 76 | escudier@igr.fr |
France | |
Institut Gustave Roussy | Recruiting |
Villejuif, France, 94805 | |
Contact: Bernard Escudier, M.D +33 (0)1 42 11 44 76 escudier@igr.fr | |
Principal Investigator: Bernard Escudier, M.D |
Principal Investigator: | Bernard Escudier, M.D | Institut Gustave Roussy |
Responsible Party: | Immutep S.A. ( F. Triebel, Chief Medical Officer ) |
Study ID Numbers: | P003, Umanis-CRO0306 |
Study First Received: | July 12, 2006 |
Last Updated: | April 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00351949 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Advanced or metastatic renal cell carcinoma IMP321 Monotherapy LAG-3 CD223 |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Urogenital Neoplasms Renal cancer Kidney Diseases |
Kidney cancer Urologic Neoplasms Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |